Exclusive Global Value Chain Quality Design Interview Released for Pre-Filled Syringes East Coast 2020
SMi Reports: Susan Neadle from Global Value Chain Quality Design to present at Pre-Filled Syringes East Coast returning to Boston, USA in April.
Boston, MA, March 17, 2020 --(PR.com)-- The 7th annual Pre-filled Syringes East Coast conference is set to return to Boston on April 27th – 28th, 2020. The highly anticipated event will offer a complete speaker line-up of industry experts analysing the growth of the pre-filled syringes market, which was valued at $4.9 billion in 2018. Delegates can expect a comprehensive overview covering a wide range of topics such as: On-body Injectors, Container Closure Interaction and Formulation, Parental gene therapy and many more.
Prior to the conference, SMi Group has caught up with Susan Neadle, Senior Director, Global Value Chain Quality Design to review her views and perspectives on the pre-filled syringes field and her presentation details for the upcoming event.
Interested parties are urged to secure their places at www.pfsamericas.com/PRcom8.
Snapshot of Susan’s interview:
The Pre-Filled Syringes market has matured greatly over recent years, what key differences have you noticed in the last year regarding significant developments?
“The growth of biologic therapies, most of which are sensitive to the digestive track, and so dependent on non-oral routes of delivery, is contributing to growth of the prefilled syringes market. This growth is further being reinforced by the convenience offered by home-use applications. Coupled with this market growth are technology improvements, to accommodate, for example, higher viscosity medicines, and more control over extractables and leachables, to cater to biologics and more sensitive drugs. Further, there is an increasing focus on human factors in development of pre-filled syringes, driving product differentiation and developing products to minimize use-error and maximize safe and effective product delivery. These ultimately drive improved patient compliance to prescribed dosing regimens.”
What do you see as the greatest challenge for you to overcome personally in the pre-filled syringes field at the moment?
“There are a few challenges, but probably the greatest I see currently is the dynamic and diverging combination product regulatory environment globally. Even the US market, whose regulations are more mature in this space, still contends with evolving regulations, like the implementation of Postmarketing Safety Reporting for combination products. For those marketing products in the EU, industry is struggling to adapt to the EU MDR Article 117 for drug-device combinations. There is not a formal regulatory definition for combination products yet, and while there are Q&A documents that have been issued, guidance has yet to be published. Manufacturers must do their best to interpret and to adjust their practices, and align with suppliers, to gain notified body opinions for their device constituents for market authorization applications, even in light of limited availability of approved notified bodies for Article 117...”
The full interview, event details and speaker line-up are available to download on the website. The brochure is available at www.pfsamericas.com/PRcom8.
Pre-filled Syringes East Coast
Conference: April 27th - 28th, 2020
Post-conference workshop Day: April 29th
Sponsored by:
Almac | Aptar Pharma | Bold insight | CSS | Credence MedSystems | Mitsubishi Gas Chemical | Owen Mumford | PHC Corporation | Polyplastics-Topas | Steris | Weiss-Aug | Zeon Speciality Materials | Zwick Roell
Contact Information:
For all media inquiries, contact Jinna Sidhu on Tel: +44 (0)20 7827 6088 / Email: hsidhu@smi-online.co.uk
About SMi Group:
Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world's most forward-thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk.
Prior to the conference, SMi Group has caught up with Susan Neadle, Senior Director, Global Value Chain Quality Design to review her views and perspectives on the pre-filled syringes field and her presentation details for the upcoming event.
Interested parties are urged to secure their places at www.pfsamericas.com/PRcom8.
Snapshot of Susan’s interview:
The Pre-Filled Syringes market has matured greatly over recent years, what key differences have you noticed in the last year regarding significant developments?
“The growth of biologic therapies, most of which are sensitive to the digestive track, and so dependent on non-oral routes of delivery, is contributing to growth of the prefilled syringes market. This growth is further being reinforced by the convenience offered by home-use applications. Coupled with this market growth are technology improvements, to accommodate, for example, higher viscosity medicines, and more control over extractables and leachables, to cater to biologics and more sensitive drugs. Further, there is an increasing focus on human factors in development of pre-filled syringes, driving product differentiation and developing products to minimize use-error and maximize safe and effective product delivery. These ultimately drive improved patient compliance to prescribed dosing regimens.”
What do you see as the greatest challenge for you to overcome personally in the pre-filled syringes field at the moment?
“There are a few challenges, but probably the greatest I see currently is the dynamic and diverging combination product regulatory environment globally. Even the US market, whose regulations are more mature in this space, still contends with evolving regulations, like the implementation of Postmarketing Safety Reporting for combination products. For those marketing products in the EU, industry is struggling to adapt to the EU MDR Article 117 for drug-device combinations. There is not a formal regulatory definition for combination products yet, and while there are Q&A documents that have been issued, guidance has yet to be published. Manufacturers must do their best to interpret and to adjust their practices, and align with suppliers, to gain notified body opinions for their device constituents for market authorization applications, even in light of limited availability of approved notified bodies for Article 117...”
The full interview, event details and speaker line-up are available to download on the website. The brochure is available at www.pfsamericas.com/PRcom8.
Pre-filled Syringes East Coast
Conference: April 27th - 28th, 2020
Post-conference workshop Day: April 29th
Sponsored by:
Almac | Aptar Pharma | Bold insight | CSS | Credence MedSystems | Mitsubishi Gas Chemical | Owen Mumford | PHC Corporation | Polyplastics-Topas | Steris | Weiss-Aug | Zeon Speciality Materials | Zwick Roell
Contact Information:
For all media inquiries, contact Jinna Sidhu on Tel: +44 (0)20 7827 6088 / Email: hsidhu@smi-online.co.uk
About SMi Group:
Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world's most forward-thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk.
Contact
SMi Group
Jinna Sidhu
+44 (0) 20 7827 6086
www.pfsamericas.com/PRcom8
Contact
Jinna Sidhu
+44 (0) 20 7827 6086
www.pfsamericas.com/PRcom8
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